TY - JOUR
T1 - A pilot randomized controlled trial comparing the efficacy of exercise, spinal manipulation, and neuro emotional technique for the treatment of pregnancy-related low back pain
AU - Peterson, Caroline D.
AU - Haas, Mitchell
AU - Gregory, W. Thomas
N1 - Funding Information:
This study was funded in part by The ONE Foundation, the research division of the Neuro Emotional Technique. The ONE Foundation did not contribute to the study in any other way. The authors declare that they have no competing interests.
Funding Information:
This study was funded by The ONE Foundation and The Tartar Foundation. CDP was funded by the National Center for Complementary & Alternative Medicine/National Institutes of Health T32AT0026888. MH was funded by the University of Western States. WTG was funded by National Institute of Child Health & Human Development/National Institutes of Health RO1 HD049541.
PY - 2012/6/13
Y1 - 2012/6/13
N2 - Background: This pilot randomized controlled trial evaluated the feasibility of conducting a full scale study and compared the efficacy of exercise, spinal manipulation, and a mind-body therapy called Neuro Emotional Technique for the treatment of pregnancy-related low back pain, a common morbidity of pregnancy.Methods: Healthy pregnant women with low back pain of insidious onset were eligible to enroll in the study at any point in their pregnancy. Once enrolled, they remained in the study until they had their babies. Women were randomly allocated into one of three treatment groups using opaque envelopes. The treatment schedule paralleled the prenatal care schedule and women received individualized intervention. Our null hypothesis was that spinal manipulation and Neuro Emotional Technique would perform no better than exercise in enhancing function and decreasing pain. Our primary outcome measure was the Roland Morris Disability Questionnaire and our secondary outcome measure was the Numeric Pain Rating Scale. Intention to treat analysis was conducted. For the primary analysis, regression was conducted to compare groups on the outcome measure scores. In a secondary responder analysis, difference in proportions of participants in attaining 30% and 50% improvement were calculated. Feasibility factors for conducting a future larger trial were also evaluated such as recruitment, compliance to study protocols, cost, and adverse events. Results: Fifty-seven participants were randomized into the exercise (n = 22), spinal manipulation (n = 15), and Neuro Emotional Technique (n = 20) treatment arms. At least 50% of participants in each treatment group experienced clinically meaningful improvement in symptoms for the Roland Morris Disability Questionnaire. At least 50% of the exercise and spinal manipulation participants also experienced clinically meaningful improvement for the Numeric Pain Rating Scale. There were no clinically meaningful or statistically significant differences between groups in any analysis. Conclusions: This pilot study demonstrated feasibility for recruitment, compliance, safety, and affordability for conducting a larger study in the future. Spinal manipulation and exercise generally performed slightly better than did Neuro Emotional Technique for improving function and decreasing pain, but the study was not powered to detect the between-group differences as statistically significant.Trial registration: ClinicalTrials.gov (Identifier: NCT00937365).
AB - Background: This pilot randomized controlled trial evaluated the feasibility of conducting a full scale study and compared the efficacy of exercise, spinal manipulation, and a mind-body therapy called Neuro Emotional Technique for the treatment of pregnancy-related low back pain, a common morbidity of pregnancy.Methods: Healthy pregnant women with low back pain of insidious onset were eligible to enroll in the study at any point in their pregnancy. Once enrolled, they remained in the study until they had their babies. Women were randomly allocated into one of three treatment groups using opaque envelopes. The treatment schedule paralleled the prenatal care schedule and women received individualized intervention. Our null hypothesis was that spinal manipulation and Neuro Emotional Technique would perform no better than exercise in enhancing function and decreasing pain. Our primary outcome measure was the Roland Morris Disability Questionnaire and our secondary outcome measure was the Numeric Pain Rating Scale. Intention to treat analysis was conducted. For the primary analysis, regression was conducted to compare groups on the outcome measure scores. In a secondary responder analysis, difference in proportions of participants in attaining 30% and 50% improvement were calculated. Feasibility factors for conducting a future larger trial were also evaluated such as recruitment, compliance to study protocols, cost, and adverse events. Results: Fifty-seven participants were randomized into the exercise (n = 22), spinal manipulation (n = 15), and Neuro Emotional Technique (n = 20) treatment arms. At least 50% of participants in each treatment group experienced clinically meaningful improvement in symptoms for the Roland Morris Disability Questionnaire. At least 50% of the exercise and spinal manipulation participants also experienced clinically meaningful improvement for the Numeric Pain Rating Scale. There were no clinically meaningful or statistically significant differences between groups in any analysis. Conclusions: This pilot study demonstrated feasibility for recruitment, compliance, safety, and affordability for conducting a larger study in the future. Spinal manipulation and exercise generally performed slightly better than did Neuro Emotional Technique for improving function and decreasing pain, but the study was not powered to detect the between-group differences as statistically significant.Trial registration: ClinicalTrials.gov (Identifier: NCT00937365).
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U2 - 10.1186/2045-709X-20-18
DO - 10.1186/2045-709X-20-18
M3 - Article
C2 - 22694756
AN - SCOPUS:84872221992
SN - 2045-709X
VL - 20
JO - Chiropractic and Manual Therapies
JF - Chiropractic and Manual Therapies
M1 - 18
ER -